The SI does not go into specific documentation requirements, other than regulation 31A (7), which covers the trials master file, of which investigator files are a part. The detail is provided in supporting guidance which is not a legal mandate, but justification is required where guidance is not followed. Therefore, Volume 10 and ICH GCP section 8 cover documents to be held in the investigator file, this includes the IB and SAEs/SUSARs information (where applicable). This doesn't break down to the investigator file to separate investigator and pharmacy files (if pharmacy files are required). Therefore the documentation to be held in respective files is defined by the sponsors quality system. However, it would be expected that if a pharmacy is involved, then as pharmacy are responsible for the receipt, dispensing and storage of IMP, they need to be aware of information related to the IMP, which would be available in the IB, but not necessarily the safety reports. As a result, IBs (or the SmPC if there is no IB) are usually expected in the pharmacy files.